Florida Surgeon General spreads COVID-19 vaccine misinformation

The COVID-19 vaccines have saved hundreds of thousands of lives, in response to a number of research. Getting the newest vaccine supplies extra safety towards poor outcomes from COVID-19. Critical unintended effects are uncommon, and the Facilities for Illness Management and Prevention and the U.S. Meals and Drug Administration decide that the advantages of vaccination outweigh the dangers.

Regardless of this, Florida Surgeon Normal Dr. Joseph Ladapo issued a assertion on Jan. 3 calling for a halt in the usage of mRNA COVID-19 vaccines, made by Pfizer/BioNTech and Moderna.

Ladapo cited unsubstantiated considerations that the small quantities of residual DNA left over within the vaccines from the manufacturing course of might combine into human DNA. “If the dangers of DNA integration haven’t been assessed for mRNA COVID-19 vaccines, these vaccines will not be applicable to be used in human beings,” he stated.

As we now have written, there’s no proof that residual DNA, which is predicted and current inside regulatory limits, can combine into vaccinated individuals’s DNA.

(For extra about residual DNA in mRNA vaccines, learn our article “COVID-19 Vaccines Have Not Been Proven to Alter DNA, Trigger Most cancers.”)

In a Dec. 14 letter despatched to Ladapo, FDA official Dr. Peter Marks stated it was “fairly implausible” that residual DNA might make its method into the nucleus of a cell and combine into chromosomal DNA there. “We want to clarify that based mostly on a radical evaluation of the complete manufacturing course of, FDA is assured within the high quality, security, and effectiveness of the COVID-19 vaccines,” Marks wrote.

Residual DNA is current in quite a lot of vaccines. For residual DNA within the mRNA vaccines to get into an individual’s DNA and have well being results would require a whole sequence of unlikely or implausible occasions. These steps would come with getting across the physique’s many defenses towards DNA exhibiting up in irregular places.

Dr. Paul Offit, director of the Vaccine Training Heart at Youngsters’s Hospital of Philadelphia, addressed claims about residual DNA in movies, saying that “it’s nearly not possible for these DNA fragments to do any hurt. They’re clinically and totally innocent.” He toldMedpage As we speak, “It’s arduous to imagine that Dr. Ladapo truly issued that assertion,” referring to Ladapo’s latest name for a halt in the usage of the mRNA vaccines.

Ladapo, appointed by Gov. Ron DeSantis as Florida surgeon common in September 2021, has unfold COVID-19 misinformation and presided over unfounded and more and more expansive suggestions towards COVID-19 vaccination in his state. In 2022, the Florida Division of Well being really helpful towards COVID-19 vaccination for wholesome kids ages 5 to 17, in addition to kids below 5. The identical 12 months, Ladapo really helpful towards mRNA COVID-19 vaccination for males ages 18 to 39, based mostly on a closely flawed evaluation of cardiac deaths by the Florida Division of Well being. Ladapo later was discovered to have edited the examine to make the vaccines seem extra harmful. 

In September 2023, he really helpful towards up to date COVID-19 vaccines for Floridians below age 65. Then, in October, he referred to as suggestions for the up to date vaccines “anti-human” and stated as a health care provider he could be “very uncomfortable” recommending them to anybody.

Ladapo initially wrote to FDA and CDC officers about residual DNA-related considerations in a Dec. 6 letter. He cited a 2007 FDA steering doc on DNA vaccines that include plasmids, a type of round DNA, incorrectly claiming that the company’s suggestions for assessing the danger of DNA from such vaccines integrating into the genome additionally apply to the mRNA vaccines. No DNA vaccines are but available on the market within the U.S.

The steering will not be related, Marks wrote in his Dec. 14 response letter. “This steering was developed for DNA vaccines themselves, not for DNA as a contaminant in different vaccines, and isn’t relevant to the mRNA COVID-19 vaccines.”

Regardless of this clarification, Ladapo responded to the FDA letter by calling for a halt in the usage of the mRNA vaccines whereas persevering with to incorrectly declare that the FDA had gone towards its personal suggestions. “The U.S. Meals and Drug Administration and the Facilities for Illness Management and Prevention have all the time performed it quick and free with COVID-19 vaccine security, however their failure to check for DNA integration with the human genome – as their very own pointers dictate – when the vaccines are identified to be contaminated with overseas DNA is insupportable,” Ladapo stated in a Jan. 3 publish on X, the platform beforehand referred to as Twitter.

As we’ve additionally beforehand written, DNA is the first ingredient of DNA vaccines, whereas it is just current in residual quantities within the mRNA vaccines. For DNA vaccines to work, there wants to be a mechanism to get the DNA into the nucleus of a cell. The mRNA vaccines, nevertheless, include primarily mRNA, which solely must get into the physique of a cell.

Even with DNA vaccines, DNA integration is barely a theoretical threat and has not been proven to be a security drawback. The FDA steering solely recommends doing integration research in animals for DNA vaccines — wherein genomic DNA in numerous tissues is analyzed for indicators of integration — if a sure degree of plasmid is proven to persist in animal tissue.

However, the out there information on the mRNA COVID-19 vaccines present no signal of genomic disruption. Marks described animal research that “display no proof for genotoxicity from the vaccine,” which means that they didn’t see proof that chromosomal DNA had been broken. 

“Furthermore, we now have entry to world surveillance information on over one billion doses of the mRNA vaccines which have been given, and there may be nothing to point hurt to the genome, corresponding to elevated charges of cancers,” Marks stated.

Editor’s notice: SciCheck’s articles offering correct well being data and correcting well being misinformation are made potential by a grant from the Robert Wooden Johnson Basis. The muse has no management over FactCheck.org’s editorial selections, and the views expressed in our articles don’t essentially mirror the views of the inspiration.